Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation

Not Applicable

Completed

• Conditions: Carotid Stenosis; Carotid Artery Diseases
• Interventions: Procedure: Modified method of eversion carotid endarterectomy; Procedure: Standard method of eversion carotid endarterectomy

• Registration Number: NCT04255316
• Lead Sponsor: Pirogov Russian National Research Medical University

Brief Summary

A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

Detailed Description

Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. Secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. Thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. It should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ICA is required, which increases the invasiveness of the operation and the difficulty of access. With prolonged stenosis, the carotid endarterectomy remains the option of choice. The modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy.

The aim of study. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• patients with stenosis of ICA 70-99% (ultrasound - NASCET and CT angiography)
• patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound - NASCET and CT angiography

Exclusion Criteria

• patients with a extensive lesion of the ICA (plaque < 2 cm),
• patients with a contralateral occlusion of the ICA
• patients with stroke in ischemic type in the acute period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified eversion	Modified method of eversion carotid endarterectomy	Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy
Standard eversion	Standard method of eversion carotid endarterectomy	Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
Assessment of total stroke rate	30 days	assessment of the total stroke rate in patients undergoing intervention after 30 days
Assessment of mortality rate	30 days	assessment of the mortality rate in patients undergoing intervention after 30 days

Secondary Outcome Measures

Name	Time	Method
Assessment of stroke frequency	12 months	assessment of stroke frequency in patients undergoing intervention after 12 months
Assessment of the incidence of internal carotid artery restenosis	3, 6, 12 months	Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months

Trial Locations

Locations (1)

The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation; 🇷🇺 Moscow, Russian Federation